ENHANCE (Elevated NKG2A and HLA-E Amplify NK/CD8 Checkpoint Engagers): A Phase 2 Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.

Start Date01 Dec 2024

Sponsor / Collaborator

Hoosier Cancer Research Network

[+3]

NCT06152523 / Not yet recruitingPhase 2IIT

Monalizumab and MEDI5752 in Patients With MSI and/or dMMR Metastatic Cancer

MSI is a molecular indicator of defective DNA mismatch repair (dMMR). The MSI/dMMR status is observed in all tumor types, representing notably 5% of metastatic colorectal cancers (mCRC), 25% of advanced endometrial cancer and 8% of metastatic gastric cancer.
MSI/dMMR cancers are highly immunogenic. MSI/dMMR tumors are characterized by a high tumor mutational burden with highly immunogenic neoantigens. These tumors are associated with an upregulation of immune checkpoints (PD1, PDL1, CTLA4, etc.) that protects MSI cancer cells from their hostile immune micro-environment, characterized by a high infiltration of activated cytotoxic T CD8+ and NK lymphocytes. Consequently, MSI/dMMR cancers are highly sensitive to ICIs, whatever the tumor location. MSI/dMMR status is a predictive biomarker for the efficacy of immunotherapy, regardless of the tumor type. Then, by several phase II and III studies The efficacy of immunotherapy has been demonstrated as front-line treatment for patients with chemotherapy-naive MSI/dMMR mCRC and gastric cancer. The phase III KEYNOTE-177 trial evaluating first-line treatment of pembrolizumab in patients with MSI/dMMR mCRC demonstrated its superiority over first-line chemotherapy, with a significant improvement of health-related quality of life. At final analysis, the median follow-up was 44.5 months. Median PFS was 16.5 versus 8.2 months (HR = 0.59; 95%CI 0.45-0.79). The hazard ratio favored pembrolizumab versus chemotherapy with a trend toward reduction in the risk of death (HR 0.74; 95% CI, 0.53-1.03; P=0.0359), despite a 60% effective crossover rate. Pembrolizumab has been approved by the FDA and the EMA for patients with newly diagnosed MSI/dMMR mCRC and is now the standard of care for this population. Also, the phase III CHECKMATE-649 trial reveal that the Combination of immunotherapy and cytotoxic chemotherapy is the new standard of care for patients with newly diagnosed metastatic oesogastric cancer. Importantly, results of the CHECKMATE-649 are outstanding for the subgroup population of MSI/dMMR gastric cancer patients (N = 44). Indeed, the unstratified hazard ratio for OS with nivolumab plus chemotherapy versus chemotherapy alone was 0.33 (95% CI 0.12-0.87) for patients with MSI/dMMR tumors. All in all, ICIs are the standard of care in first-line setting for patients with mCRC or metastatic oesogastric cancer. Besides, several phase II studies suggest that ICI combinations might overcome primary resistance to anti-PD1 monotherapy These data justify the development of bispecific monoclonal antibodies targeting both PD1 and CTLA4 such as MEDI5752. MEDI5752 has been developed based on the observation that there is a higher expression of PD-1/CTLA-4 on tumor resident versus peripheral T cells. Preclinical data show MEDI5752 fully suppresses PD-1 and preferentially inhibits CTLA-4 in the tumor versus the periphery, which is meant to uncouple CTLA-4 dependant peripheral toxicity from antitumor activity Natural killer cells are integral to the functioning of the innate immune system and play an important role in innate antitumor immunity. There is a growing body of evidence for targeting the NKG2A/HLA-E axis in combination with other ICIs to sensitize tumors to ICI therapy. NKG2A recognizes the non-classical HLA class I molecule HLA-E. The NKG2A receptor is found on peripheral NK cells and subsets of T cells in cancer patients. It is also present in tumor-infiltrating NK and cytotoxic T cells. Importantly, NK cells and the NKG2A/HLA-E axis play a crucial role in MSI/dMMR tumors. Therefore, a combined blockade of non-redundant checkpoint pathways to unleash NK and T cells seems particularly promising for MSI/dMMR neoplasms. Monalizumab specifically binds and blocks the inhibitory receptor NKG2A. Monalizumab has been investigated in combination with ibrutinib (in chronic lymphoid leukemia), cetuximab +/- durvalumab (in squamous cell carcinoma of the head and neck, and in solid tumors), durvalumab +/- FOLFOX (in solid tumors). In the first-in-human dose escalation of monalizumab plus durvalumab, a manageable toxicity profile was shown.
Taken together, these data provide a strong rational to combine an inhibitor of the NKG2A/HLA-E axis with a bispecific monoclonal antibody targeting both PD1 and CTLA4 for patients with metastatic MSI/dMMR cancers.

Start Date01 Dec 2023

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

NCT05903092 / RecruitingPhase 2IIT

A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer (MOZART)

The study treatment will consist of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide plus durvalumab plus monalizumab every 3 weeks for 4 cycles. After 4 cycles, subjects will continue maintenance treatment with durvalumab plus monalizumab every 4 weeks until disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal of consent. Patients who have received one prior cycle of treatment before enrolling on the study will receive a total of 4 cycles with monalizumab, durvalumab, and chemotherapy. There will be a safety lead-in phase, including 6 to 12 patients, to confirm the safety of the proposed dose of monalizumab to use in combination with chemotherapy and durvalumab.

Start Date26 Sep 2023

Sponsor / Collaborator

Hoosier Cancer Research Network

[+2]

100 Clinical Results associated with Monalizumab

100 Translational Medicine associated with Monalizumab

100 Patents (Medical) associated with Monalizumab

Literatures (Medical) associated with Monalizumab

13 Sep 2024·Future Oncology

PACIFIC-9: Phase III trial of durvalumab + oleclumab or monalizumab in unresectable stage III non-small-cell lung cancer

Article

Author: Mann, Helen ; Yoh, Kiyotaka ; Gopinathan, Aarthi ; Bielecka, Zofia Felicja ; Barlesi, Fabrice ; Cho, Byoung Chul ; Newton, Michael ; Aggarwal, Charu ; Goldberg, Sarah B ; Zimmer Gelatti, Ana Caroline

Evidence from the Phase III PACIFIC trial established durvalumab, a monoclonal antibody (mAb) targeting PD-L1, following concurrent chemoradiotherapy (cCRT) as a global standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC). There remains an unmet need to improve upon the outcomes achieved with the PACIFIC regimen. Combining durvalumab with other immunotherapies may improve outcomes further. Two such immunotherapies include oleclumab, an mAb targeting CD73, and monalizumab, an mAb targeting NKG2A. Both agents demonstrated antitumor activity in early-phase trials. PACIFIC-9 (NCT05221840) is an international, double-blind, randomized, placebo-controlled, Phase III trial comparing durvalumab plus either oleclumab or monalizumab with durvalumab plus placebo in patients with unresectable, stage III NSCLC and no disease progression following cCRT.Clinical Trial Registration: NCT05221840 (ClinicalTrials.gov).

01 May 2024·Combinatorial chemistry & high throughput screening

A Novel Natural Killer Cell-related Gene Signature for Improving the Prediction of Prognosis and Immunotherapy Response in Bladder Cancer

Article

Author: Yang, Guanghua ; Li, Shuai ; Wei, Xifeng ; Liu, Ranlu ; Ma, Xudong

Background::

Bladder cancer (BLCA) is a commonly diagnosed cancer worldwide that exhibits high rates of recurrence and metastasis. Immunotherapy is increasingly being recognised in the clinical management of bladder cancer. In addition, the prospect of developing Natural Killer (NK) cell-related immunotherapy is promising in BLCA.

Methods::

We established and verified a prognostic signature based on NK cell-related gene expression. We then calculated the NKscore of BLCA samples and correlated it with the clinical outcomes, molecular subtypes of BLCA, tumour microenvironment (TME), and predicted efficacy of immune checkpoint inhibitors (ICI) and chemotherapy drugs to thoroughly explore the implications of the NKscore. Finally, the role of the NK signature gene HECTD1 in BLCA was verified by Quantitative Real-time PCR, Cell Counting Kit-8 Assay (CCK-8), Transwell Assay and Colony Formation Experiment.

Results::

We analysed NK cell-associated genes and identified six genes with significant prognostic relevance. A high NK score significantly represents a worse prognosis. NKscore was significantly correlated with seven types of classical molecular subtype classifications of BLCA. In addition, NKscore positively correlates with NK-related immune checkpoints, suggesting that emerging NK cell immune checkpoint inhibitors, such as monalizumab, may have potential therapeutic promise for patients with high NKscore. The results of the T cell inflamed score (TIS) and tumour immune dysfunction exclusion (TIDE) score confirmed the suitability of immunotherapy for patients with a high NK score. Likewise, patients with a high NK score may be more suitable for several significant chemotherapeutic drugs. Functional experiments showed that the knockdown of HECTD1 significantly attenuated the proliferation, migration, and invasion ability of tumour cells.

Conclusion::

To sum up, the capability of our signature to predict prognosis and immunotherapy response was robust. Hopefully, these results will provide new insights for BLCA research and patient immunotherapy.

01 Feb 2024·Journal for immunotherapy of cancer

Phase 1/2 study of monalizumab plus durvalumab in patients with advanced solid tumors

Article

Author: Cheng, Lin-Yang ; Ascierto, Maria L ; Banerjee, Susana ; Naidoo, Jarushka ; Carneiro, Benedito A ; Diamond, Jennifer R ; Palmer, Doug C ; Das, Mayukh ; Alonso-Gordoa, Teresa ; Wang, Ding ; Kourtesis, Panagiotis ; Standifer, Nathan E ; Hellmann, Matthew D ; Patel, Sandip P

Background:

The combination of monalizumab (anti-NKG2A/CD94) and durvalumab (anti-programmed death ligand-1) may promote antitumor immunity by targeting innate and adaptive immunity. This phase 1/2 study of monalizumab and durvalumab evaluated safety, antitumor activity, and pharmacodynamics in patients with advanced solid tumors.

Main body:

Immunotherapy-naïve patients aged ≥18 years with advanced disease, Eastern Cooperative Oncology Group performance status of 0–1, and 1–3 prior lines of systemic therapy in the recurrent/metastatic setting were enrolled. In part 1 (dose escalation), patients received durvalumab 1500 mg every 4 weeks (Q4W) with increasing doses of monalizumab Q2W/Q4W (n=15). Dose expansion in part 1 included patients with cervical cancer (n=15; durvalumab 1500 mg Q4W and monalizumab 750 mg Q2W) or metastatic microsatellite stable (MSS)-colorectal cancer (CRC) (n=15; durvalumab 1500 mg Q4W and monalizumab 750 mg Q4W). In part 2 (dose expansion), patients with MSS-CRC (n=40), non-small cell lung cancer (NSCLC; n=20), MSS-endometrial cancer (n=40), or ovarian cancer (n=40) received durvalumab 1500 mg Q4W and monalizumab 750 mg Q2W. The primary endpoint was safety. Secondary endpoints included antitumor activity per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). Exploratory analyses included assessment of T-cell and natural killer (NK) cell activation and proliferation in peripheral blood and the tumor microenvironment (TME). The study enrolled 185 patients (part 1, 45; part 2, 140). No dose-limiting toxicities were observed and the maximum tolerated dose was not reached. In part 2, the most common treatment-related adverse events were fatigue (12.1%), asthenia (9.3%), diarrhea (9.3%), pruritus (7.9%), and pyrexia (7.1%). In the expansion cohorts, response rates were 0% (cervical), 7.7% (MSS-CRC), 10% (NSCLC), 5.4% (ovarian), and 0% (MSS-endometrial). Sustained NK cell activation, CD8+T-cell proliferation, increased serum levels of CXCL10 (C-X-C motif chemokine ligand 10) and CXCL11, and increased tumor infiltration of CD8+and granzyme B+cells were observed.

Conclusions:

Although efficacy was modest, monalizumab plus durvalumab was well tolerated and encouraging immune activation was observed in the peripheral blood and TME.

Trial registration number:

NCT02671435.

News (Medical) associated with Monalizumab

06 Dec 2024

·www.businesswire.com

Innate Pharma and the Institute for Follicular Lymphoma Innovation (IFLI) Announce up to $7.9M Investment From IFLI to Support IPH6501 Development in Follicular Lymphoma

MARSEILLE, France & DIAMOND BAR, Calif.--( BUSINESS WIRE )--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”), together with the Institute for Follicular Lymphoma (IFLI) today announced that they have entered into an agreement to clinically study the potential of IPH6501, Innate's anti-CD20 ANKET ® in follicular lymphoma (FL). Innate’s ongoing Phase 1/2, open-label, multicenter trial investigating the safety, tolerability, and preliminary antineoplastic activity of IPH6501 in patients with relapsed and/or refractory CD20-expressing Non-Hodgkin Lymphoma will also include patients with relapsed / refractory (R/R) FL. To support the Phase 1/2 trial and inclusion of FL patients, IFLI will initially invest 3m USD into new shares of Innate, issued through a capital increase reserved to IFLI at a price of €1.56 per share and representing 2.26% of the share capital of Innate. IFLI may also invest up to an additional 4.9m USD into new shares of Innate, depending on the completion of certain milestones, at a price to be determined at the time of the said investments. “ At Innate Pharma, we are deeply committed to advancing innovative research and development to improve outcomes for patients with non-Hodgkin lymphoma and this agreement with the Institute for Follicular Lymphoma Innovation will contribute to our mission to bring forward therapeutic options that address critical needs and enhance the quality of life for those affected by this challenging disease ,” said Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma . “ IFLI believes IPH6501 holds great promise for improving patient outcomes in non-Hodgkin lymphomas including follicular lymphoma ,” said Dr. Michel Azoulay, Chief Medical Officer of IFLI . “ We are delighted to support Innate and the investigation of IPH6501 in FL patients and, upon milestone achievement, to continue to support future clinical development of IPH6501 in FL. This collaboration provides a model for how IFLI’s philanthropic investments can catalyze FL development .” You can find more details on the transaction in the attached PDF . About The Institute for Follicular Lymphoma Innovation The Institute for Follicular Lymphoma Innovation (IFLI) is a global, non-profit, private foundation dedicated to accelerating the development of innovative treatment options for patients with follicular lymphoma (FL). IFLI supports cutting-edge research and technology to lead to the development and commercialization of novel therapeutics and/or biomarkers for the treatment of FL, and to understand the biology of FL. The foundation deploys its budget across grants, project-based partnerships, and venture philanthropic investments to achieve its innovation goals. IFLI promotes collaboration and works to enable data sharing and the exchange of knowledge and expertise among researchers and institutions advancing FL research. Learn more at www.i-fli.org . About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET ® ( A ntibody-based NK cell E ngager T herapeutics) proprietary platform. Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET ® multi-specific NK cell engagers to address multiple tumor types. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on Twitter and LinkedIn . Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “expect” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Clinical StudyImmunotherapy

20 Nov 2024

·www.businesswire.com

Innate Pharma Releases Its 2025 Financial Calendar

MARSEILLE, France--( BUSINESS WIRE )--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today released its 2025 financial calendar: March 27, 2025 : Publication of 2024 financial statements May 13, 2025 : Publication of revenue and cash position for 1Q2025 May 22, 2025 : Annual General Shareholders Meeting September 17, 2025 : Publication of half year financial statements November 13, 2025 : Publication of revenue and cash position for 3Q2025 All financial reports are released before market open CET. All corporate information, such as the Company’s financial statements and corporate presentations, is available in the Investors section on https://www.innate-pharma.com . About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: monoclonal antibodies, multi-specific NK Cell Engagers via its ANKET ® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC). Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, several ANKET ® drug candidates to address multiple tumor types as well as IPH4502 a differentiated ADC in development in solid tumors. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X . Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “expect” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website ( http://www.amf-france.org ) or on Innate Pharma’s website ( www.innate-pharma.com ), and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Immunotherapy

19 Nov 2024

·www.businesswire.com

Innate Pharma Announces Publication in Science Immunology Highlighting Innovative Next-generation ANKET® IPH6501

MARSEILLE, France--( BUSINESS WIRE )--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today announced the publication in Science Immunology of preclinical data demonstrating the potential of IPH6501, Innate’s proprietary NK cell engager including an IL-2v and targeting CD20 from the ANKET ® platform. IPH6501 is currently evaluated in a Phase 1/2 clinical trial in B-cell non-Hodgkin lymphoma (B-NHL) (NCT06088654). The data published shows that IPH6501, also called CD20-NKCE-IL2v in the publication, boosts NK cell proliferation and cytotoxicity, showing activity against a range of B-NHL cell lines, including those with low CD20 density. In vivo studies in nonhuman primates and tumor mouse models further validated its efficacy and revealed that IPH6501 induces peripheral NK cell migration at the tumor site. “ These new findings underscore the remarkable potential of IPH6501 to transform the treatment landscape for B-NHL. IPH6501 showed greater killing efficacy over a T cell engager targeting CD20 in in vitro preclinical models while presenting reduced toxicities compared with those commonly associated with T cell therapies. We are particularly encouraged by results that reveal IPH6501’s ability to drive NK cell migration directly to tumor sites, highlighting its potential as a game-changer in immuno-oncology. These findings are a testament to the promise of NK cell therapies to deliver safer and more targeted solutions for patients in need, ” commented Eric Vivier, DVM, PhD, Chief Scientific Officer of Innate Pharma . The data published further support the current clinical development plan of IPH6501 in Relapsed/Refractory B-NHL. About ANKET ® ANKET ® ( A ntibody-based NK cell E ngager T herapeutics) is Innate's proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. About IPH6501 IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not a subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA 2023, Carrette, SITC 2024, Demaria et al, Science Immunology 2024). IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with Relapsed and/or Refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: monoclonal antibodies, multi-specific NK Cell Engagers via its ANKET ® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC). Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, several ANKET ® drug candidates to address multiple tumor types as well as IPH4502 a differentiated ADC in development in solid tumors. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X . Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “expect” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, www.innate-pharma.com , and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

ImmunotherapyClinical Study

100 Deals associated with Monalizumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Monalizumab	-	DB12824

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	US	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	CN	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	JP	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	AU	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	BR	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	CA	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	CO	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	FR	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	DE	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	IT	AstraZeneca PLC	07 Feb 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2024	Phase 2	Extensive stage Small Cell Lung Cancer First line NKG2A/CD94 \| HLA-E	6	Platinum-based chemotherapy + Durvalumab + Monalizumab	qscdigrsmq(ubkvrhizds) = wzygaecput uafovulllk (pwzprsiujm )	Positive	08 Sep 2024
NCT03822351 (COAST, ASCO2024) Manual	Phase 2	Unresectable Lung Non-Small Cell Carcinoma	189	durvalumab	thpvnwfzdf(hkhvjbldlu) = wvnzteiuua jalmaknzal (aaieycqpme, 14.3 - 35.9) View more	Positive	24 May 2024
				durvalumab+oleclumab	thpvnwfzdf(hkhvjbldlu) = wozponzleq jalmaknzal (aaieycqpme, 23.1 - 48.4) View more
NCT03794544 (NeoCOAST, AACR2024) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	47	durvalumab	jeazmmxvcx(plyprzttlq) = Percent CD73+ TC and B cell abundance was higher in patients with MPR vs those without MPR in the durva + ole arm, but not in the durva monotherapy or durva + mona arms. Increased CD8 T cell and NK cell abundance was not associated with MPR in any arm. rgfikapalb (blkibapkfd ) View more	Positive	22 Mar 2024
				durvalumab+oleclumab
NCT03794544 (AACR2022) Manual	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	84	Durvalumab	uagiwbyali(tlrpgpkzme) = hukxbeizpk eexvqfffal (tnaaicoaun, 2.4 - 29.2) View more	Positive	15 Jun 2022
				Durvalumab+Oleclumab	uagiwbyali(tlrpgpkzme) = sxxngfevtt eexvqfffal (tnaaicoaun, 5.4 - 41.9) View more
NCT03822351 (COAST, Pubmed \| J Urol)	Phase 2	Non-small cell lung cancer stage III Consolidation	189	Durvalumab	dohqksjjfg(cpqoaymlki) = bkwkuzlvsp wdcsrzhihr (zrcsfglsyf, 9.6 - 29.2)	Positive	22 Apr 2022
				Durvalumab+Oleclumab	dohqksjjfg(cpqoaymlki) = jaakdeiksc wdcsrzhihr (zrcsfglsyf, 18.8 - 43.2)
NCT02643550 (ESMO_IO2021) Manual	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck First line	40	durvalumab+Monalizumab+cetuximab	xfktlhzthd(dlyamqjxij) = lczksfejqd dddlifudbk (qarkxqeptn, 20 - 48) View more	Positive	09 Dec 2021
NCT04307329 (MIMOSA, ESMO_BC2021)	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast	-	Monalizumab + Trastuzumab	xiulgqocer(bptwaxklen) = zazsndlhco rxvwaytypl (jvmmjwrwda )	-	05 May 2021
NCT02643550 (ASCO2020) Manual	Phase 2	Head and neck cancer metastatic	40	cetuximab+monalizumab	kisafblafl(biqqrtjuwi) = jspqjiksda bbzqbdzdsh (wwcyhlpiom, 11 - 35) View more	Positive	29 May 2020
NCT02557516 (CTgov)	Phase 1/2	Chronic Lymphocytic Leukemia	22	monalizumab (Phase 1 Level 1 - 1 mg/kg)	urssgvejft(ljhnmvpmzx) = uomykogyob gymkjjaodp (mamzzoxfoi, qrmitzokag - hizsnzvwep) View more	-	17 Dec 2019
				monalizumab (Phase 1 Level 2 - 2 mg/kg)	urssgvejft(ljhnmvpmzx) = fexxuknvcw gymkjjaodp (mamzzoxfoi, qgqgyblwuv - iwqzczjseg) View more
NCT02459301 (IND221, Pubmed \| Clin Cancer Res) Manual	Phase 1	Neoplasms	58	IPH2201	iuhjzplyyi(wrixrtdxlg) = znbwoeqqdy llwvylzfjz (noahgpectd ) View more	Positive	15 Oct 2019

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